A federal magistrate judge in New York has ordered the Food and Drug Administration (FDA) to begin proceedings to withdraw approval for the subtherapeutic use of certain antibiotics in animal feed, agreeing with the Natural Resources Defense Council (NRDC) and a coalition of advocacy organizations that the agency had a statutory duty to hold withdrawal proceedings after issuing notices in 1977 of its intent to withdraw approval because the use of such drugs had not been shown to be safe. NRDC v. FDA, No. 11-3562 (U.S. Dist. Ct., S.D.N.Y., decided March 22, 2012). According to the court, “if the Secretary finds that an animal drug has not been shown to be safe, he is statutorily required to withdraw approval of that drug, provided that the drug sponsor has notice and an opportunity for a hearing.”

Further details about the lawsuit appear in Issue 396 of this Update. Questions about whether the agency has unreasonably delayed acting on citizen petitions filed by the plaintiffs in 1999 and 2005 requesting that FDA take action on the use of antibiotics in animal feed remain pending.

The court indicated that the proceedings must begin, but it did not express an opinion as to the outcome, recognizing that the drug sponsors must be given the opportunity to prove that the antibiotic use is safe. FDA was apparently under an obligation to begin such proceedings once it issued notices expressing concerns about the purported development of antibiotic-resistant “superbugs” in humans from the widespread use of antibiotics—penicillin and tetracycline—in livestock feed. Hearings were never scheduled despite requests by numerous drug sponsors, and the agency’s approval remained in place. According to the court, “In the intervening years, the scientific evidence of the risks to human health from the widespread use of antibiotics in livestock has grown, and there is no evidence that the FDA has changed its position that such uses are not shown to be safe.”

FDA indicated that the process begun in 1977 and formally abandoned in December 2011 was outdated and that it intended to take other action to address any potential food safety issues. Among other matters, it issued non-binding draft guidance in June 2010 urging the judicious use of medically important antimicrobial drugs in food-producing animals. It also argued that the lawsuit was now moot because of the abandoned process. The court disagreed and further noted, in granting the plaintiffs’ motion for summary judgment on their first claim, “The FDA has not issued a single statement since the issuance of the 1977 (notices) that undermines the original findings that the drugs have not been shown to be safe.”

Public Citizen quoted NRDC attorney Jen Sorenson as saying, “Thanks to the Court’s order, drug manufacturers will finally have to do what FDA should have made them do 35 years ago: prove that their drugs are safe for human health, or take them off the market.” See Reuters, March 22, 2012; Public Citizen News Release, March 23, 2012.